FDA Adverse Event
Malfunction
Summary report: N
CLARITY HEARING SCREENER
MDR report key: 1714571
·
Received June 4, 2010
Report
- Report Number
- 1419887-2010-00002
- Event Type
- Malfunction
- Date Received
- June 4, 2010
- Report Date
- June 4, 2010
- Manufacturer
- SONAMED CORP
- Product Code
- GWJ
- PMA / PMN Number
- K952080
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AFTER PURCHASING SONAMED, NATUS MEDICAL INCORPORATED ENGAGED IN DUE DILIGENCE TO DETERMINE WHETHER THERE WAS ADEQUATE SCIENTIFIC EVIDENCE TO SUPPORT ALL CLAIMS BEING MADE FOR THE PURCHASED SONAMED PRODUCTS. AFTER CONSIDERABLE EFFORT, NATUS MEDICAL INCORPORATED DETERMINED THAT FOR LEGAL AND SCIENTIFIC REASONS THERE IS INSUFFICIENT EVIDENCE TO SUPPORT ANY CLAIMS FOR SAFETY AND EFFICACY ON THE SONAMED CLARITY DEVICES. ACCORDINGLY, NATUS MEDICAL INCORPORATED CONCLUDED THAT THE CLARITY DEVICES CANNOT PERFORM AS INTENDED OR AS REASONABLY EXPECTED. THUS NATUS MEDICAL INCORPORATED CONCLUDED THAT SUCH PRODUCT MUST BE RECALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CLARITY HEARING SCREENER | GWJ | SONAMED CORP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |